Actively Recruiting
MeDe Study: Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome
Led by Maasstad Hospital · Updated on 2026-06-01
110
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Carpal tunnel syndrome (CTS) causes pain, numbness, or tingling in the hand and wrist due to pressure on the median nerve. This trial evaluates two surgical approaches for adults with CTS: standard surgery releasing only the carpal tunnel, and extended surgery releasing both the carpal tunnel and the Lacertus fibrosus, a ligament higher in the arm that may also compress the nerve. The study aims to find which surgery better reduces symptoms and improves patient outcomes. Participants will be randomly assigned to one of two groups. One group will receive the standard carpal tunnel release surgery, which involves cutting the transverse carpal ligament to relieve nerve pressure. The other group will undergo an extended surgery that also releases the Lacertus fibrosus by making an additional incision near the elbow to decompress the median nerve further. Both procedures are outpatient and done under local anesthesia. During the 12 months after surgery, participants will be followed regularly. Researchers will assess symptoms using the Boston Carpal Tunnel Questionnaire and monitor functional status, pain, sensation, strength, work ability, complications, and quality of life. They will also track if any participants need additional surgery. The study includes physical exams and patient questionnaires throughout the follow-up period to evaluate recovery and treatment effects.
CONDITIONS
Brief Title
MeDe Study: Comparing Median Nerve Decompression at the Carpal Tunnel Alone Versus Median Nerve Decompression at Both the Carpal Tunnel and Lacertus Fibrosis in Adults With Carpal Tunnel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Confirmed carpal tunnel syndrome by EMG or nerve ultrasound
- Patient chooses surgical treatment for carpal tunnel syndrome
You will not qualify if you...
- Previous surgery to decompress the median nerve on the same wrist or forearm
- Severe thenar muscle atrophy based on clinical exam
- Simultaneous nerve decompression in the same arm (e.g., cubital tunnel, Guyon, or radial nerve release)
- Neurological disorders affecting peripheral nerves (e.g., spinal cord injury, muscular dystrophy, dystonia, ALS)
- Malunion of the distal radius
- Impaired hand function
- Pregnancy
- Inability to complete study forms due to insufficient understanding of Dutch language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Outpatient procedure with recovery time varying per participant
Participants undergo surgery to relieve pressure on the median nerve. They receive either carpal tunnel release alone or combined carpal tunnel and Lacertus fibrosus release.
1 surgery visit (outpatient)
Duration - Up to 12 months
Participants are followed for up to 12 months after surgery to monitor symptoms, function, complications, and quality of life.
Regular follow-up visits up to 12 months after surgery
Trial Site Locations
Total: 2 locations
1
Maasstad Ziekenhuis
Rotterdam, South Holland, Netherlands, 3079 DZ
Actively Recruiting
2
Spijkenise Medisch Centrum
Rotterdam, South Holland, Netherlands, 3201 GZ
Actively Recruiting
Research Team
S
Sebastian Poggio Voormolen, BSc, PhD candidate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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